| ENDOSCOPE HOLDER (182214) (K261573) | Aktormed GmbH | 2026-07-20 |
| Sleep Apnea Feature (v2.0) (K261011) | Samsung Electronics Co., Ltd. | 2026-07-20 |
| Hi-D Imaging 4TAVR (K261535) | Hi-D Imaging AG | 2026-07-20 |
| Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Aqua Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Violet Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Dark Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Dark Violet Blue (K254285) | Hartalega NGC Sdn. Bhd. | 2026-07-20 |
| Inno-Hook™ Disposable Clip Appliers (Ligating Clips) and Inno-Hook™ Ligating Clips (K254231) | Taiwan Surgical Corporation | 2026-07-20 |
| Diode laser hair removal machine (QDTM-04) (K261693) | Beijing Nubway S&T Co., Ltd. | 2026-07-17 |
| ZEISS CLINIC 360 (K260694) | Carl Zeiss Meditec, AG | 2026-07-17 |
| LED LCD Monitor (OEV-271H) (K261614) | Lg Electronics.Inc | 2026-07-17 |
| Natural Cycles (K253694) | Natural Cycles Nordic AB | 2026-07-17 |
| Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero® -C Cervical Cage System; AVS® Anchor-C Cervical Cage System; AVS® TL PEEK Spacer; AVS® PL PEEK Spacers; AVS® Navigator PEEK Spacer; AVS® AS PEEK Spacer; Monterey™ AL Interbody System; Aleutian IBF System; Cascadia Interbody System; Chesapeake Stabilization System; Sahara Stabilization System; SANTORINI™ Corpectomy Cage System; MOJAVE Interbody System; VLIFT VERTEBRAL BODY REPLACEM (K262061) | Stryker Spine | 2026-07-17 |
| Drivewire 35 Guidewire (K254006) | Rapid Medical Ltd. | 2026-07-17 |
| LoFric Origo Pro Coudé (K261658) | Wellspect AB | 2026-07-17 |
| Cubresa BrainPET (K253963) | Cubresa, Inc. | 2026-07-17 |
| BIOFIRE® FILMARRAY® Tropical Fever Panel Control Kit (K261475) | Biofire Defense, LLC | 2026-07-17 |
| SportSuite Vision Software (DEN250040) | Stryker Endoscopy | 2026-07-17 |
| Virasight (K251952) | Virasoft Corporation | 2026-07-17 |
| AssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test Cup (K261984) | Assure Tech., LLC | 2026-07-17 |
| CHZL Red Light Therapy Hair Growth Cap (Model(s):CHZL-120BK-L52D,CHZL-120BK-L53D,CHZL-120BK-L54D) (K261675) | Shenzhen Chuanghong Zhilian Technology Co., Ltd. | 2026-07-17 |
| Catalyft PL Expandable Interbody System (K253011) | Medtronic Sofamor Danek USA, Inc. | 2026-07-17 |
| Dental Zirconia Blank & Coloring Liquid (K261046) | Hunan Qinghao Puzhong Technology Co., Ltd. | 2026-07-17 |
| cobas® BV/CV (K260021) | Roche Molecular Systems, Inc. | 2026-07-16 |
| Skin Air Cooling System (QALF-01) (K261674) | Beijing Nubway S&T Co., Ltd. | 2026-07-16 |
| TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFL-SHB );TriMed Non-Spanning Wrist Fusion Plates (NSFR-SHB ) (K262032) | TriMed, Inc. | 2026-07-16 |
| Cable-Ready® Cable Grip System (K261271) | Pioneer Surgical Technology, Inc. | 2026-07-16 |
| Palisades™ Buttress Plate System (K261309) | Bethesda Medical Devices, LLC | 2026-07-16 |
| Socrates Aspiration System (Socrates 70 Aspiration Catheter) (K260002) | Scientia Vascular, Inc. | 2026-07-16 |
| Endomat Select (UP220) (K261706) | KARL STORZ SE & CO. KG | 2026-07-16 |
| Aventus Thrombectomy System (K262030) | Inquis Medical | 2026-07-15 |
| Profoject™ Pen Needles (Model A; Model B) (K260739) | CMT Health PTE., Ltd. | 2026-07-15 |
| WRAP System (K260050) | Huneo, LLC | 2026-07-15 |
| Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor System (K261353) | Kyocera Medical Technologies, Inc. | 2026-07-15 |
| NanoZoomer S20MD Slide scanner system; NanoZoomer S360MD Slide scanner system (K253606) | Hamamatsu Photonics K.K. | 2026-07-15 |
| Atlas Spine HiRISE™ Expandable Cervical-p Corpectomy Implant (K252822) | Atlas Spine, Inc. | 2026-07-15 |
| ThinkSono Guidance (K260338) | ThinkSono GmbH | 2026-07-15 |
| XPREEN LED Light Therapy Masks (XPRE322, XPRE326, XPRE327, XPRE342, XPRE368, XPRE422, XPRE434, XPRE451, XPRE455, XPRE457, XPRE448, XPRE335, XPRE350, XPRE420, XPRE436, XPRE339, XPRE445) (K261407) | Dongguan Miqiang Technology Co., Ltd. | 2026-07-15 |
| SkeletonPlanner (K260206) | UPlanner B.V. - Presurgeo | 2026-07-15 |
| EnSite™ X EP System (K262006) | Abbott Medical | 2026-07-15 |
| Better Diagnostics Dental Assist (BDDA) Version 1.0 (K260851) | Better Diagnostics AI Corp. | 2026-07-15 |
| Symmetrix™ L Spinal System (K261020) | Medtronic Sofamor Danek USA, Inc. | 2026-07-14 |
| LIXI (LXOSFM1) (K253662) | Luwi, LLC | 2026-07-14 |
| Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System (K261284) | Alphatec Spine, Inc. | 2026-07-14 |
| IERO Mobility Scooter (IERO-01) (K261232) | Jochu Technology Co., Ltd. | 2026-07-14 |
| Universal Seal (5-12 mm) (K261249) | Intuitive Surgical, Inc. | 2026-07-14 |
| VisuBreath (K261633) | Affirm Medical Technologies II, LLC | 2026-07-14 |
| Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US, 72704/27US) Ambu® NeurolineTM Cup MRI/CT-set (Models 72704/21-1010US, 72704/21-1010US, 72704/23-1010US, 72704/25-1010US, 72704/27-1010US) Ambu® NeurolineTM Cup MRI/CT-mini set (Models 72704/21-0301US, 72704/23-0301US, 72704/25-0301US, 72704/27-0301US) (K260578) | Ambu A/S | 2026-07-14 |
| Accoat Guide Wire (K253667) | Sp Medical A/S | 2026-07-14 |
| Hearing assist (K254044) | Meta Platform Technologies, LLC | 2026-07-13 |
| Rapid Vessel Occlusion (Rapid VO) (K261085) | iSchemaview | 2026-07-13 |
| Ultra-Fine™ SAFETY Insulin Syringe (K260208) | embecta Medical II, LLC | 2026-07-13 |
| Wearable Breast Pump (Model S32A) (K261199) | Shenzhen TPH Technology Co., Ltd. | 2026-07-13 |
| Volnewmer™ (K253504) | Classys, Inc. | 2026-07-13 |
| Merit MAK Nitinol/Gold-Tungsten Guide Wire (K261640) | Merit Medical Ireland , Ltd. | 2026-07-13 |
| SLIM Microcatheter (K260199) | Balt USA, LLC | 2026-07-13 |
| Avara Viewer (K262120) | Avara Software | 2026-07-10 |
| Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert; Trident® Crossfire® 0° Polyethylene Insert; Trident ® Crossfire ® 10° Polyethylene Insert;System 12 Crossfire® 10° Insert; Trident® 0° Constrained Acetabular Insert; Trident® Constrained Acetabular Liner;Trident® All Poly Constrained Acetabular Insert; Crossfire® Eccentric Insert 10°; Artisan® Bone Plug;UHR® Universal Head Bipolar Component (K261624) | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2026-07-10 |
| Flowflex Plus RSV + Flu A/B + COVID Rapid Test (K261212) | ACON Laboratories, Inc. | 2026-07-10 |
| SmartCT (R3.0 (L10)) (K253670) | Philips Medical Systems B.V. | 2026-07-10 |
| Cochlear™ Osia® 3(I) Sound Processor;Cochlear™ Osia® 3 Sound Processor;Cochlear™ Osia® 3 Charger;Cochlear™ Osia® 3 Aqua+;Cochlear™ Osia® Fitting Software 3;Cochlear™ Osia® Smart App;Cochlear™ Osia® System (K260902) | Cochlear Americas | 2026-07-10 |
| ClearSafe Closed System (K261041) | MedSource Labs, LLC | 2026-07-10 |
| NYES Tuff Cuff L3 Disposable Gowns (K261949) | New York Embroidery Studio | 2026-07-10 |
| SedLine Sedation Monitor (K260880) | Masimo Corporation | 2026-07-10 |
| LungFlow Airway Catheter (K254037) | Free Flow Medical, Inc. | 2026-07-10 |
| AI Contouring (VA10A) (K261306) | Varian Medical Systems | 2026-07-10 |
| POSEIDON ST (K261031) | Signus Medinzintechnik GmbH | 2026-07-10 |
| WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent System (K261978) | Boston Scientific Corporation | 2026-07-10 |
| Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric Tube - 20 French (0092100); Blakemore Esophageal-Nasogastric Tube - 16 French (0092300) (K253514) | C.R. Bard, Inc. | 2026-07-10 |
| Sofia Lyme FIA; Sofia 2 Campylobacter FIA (K254295) | Ortho-Clinical Diagnostics, Inc. (QuidelOrtho) | 2026-07-10 |
| Capenergy C Equipments RF C200 and C400 Drakarian (K253480) | Capenergy Medical S.L. | 2026-07-10 |
| Electric Wheelchair (DY611A-2, DY612A-1) (K261149) | Zhejiang Lumbre Electric Appliance Co., Ltd. | 2026-07-10 |
| HYDROS Robotic System (HY1000);HYDROS Handpiece (HH1000);HYDROS TRUS Probe (HU1000) (K260723) | Procept Biorobotics | 2026-07-09 |
| Monodek™ (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical Suture (K261988) | Teleflex Medical, LLC | 2026-07-09 |
| Zeta TMS Navigation System (K261471) | Zeta Surgical, Inc. | 2026-07-09 |
| Millipede88 Access Catheter (K253901) | Perfuze, Ltd. | 2026-07-09 |
| Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982) (K261968) | Smith & Nephew, Inc. | 2026-07-09 |
| MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV Catheter (K260539) | MedSource Labs, LLC | 2026-07-09 |
| PINKSLIP Water-Based Personal Lubricant and Moisturizer (K261177) | PINKSLIP, LLC | 2026-07-09 |
| UbiqVue™ 2AYe Cardiac System (UX2253) (K261569) | Lifesignals, Inc. | 2026-07-09 |
| SmartGuard Technology; Predictive Low Glucose Technology (K261962) | Medtronic MiniMed | 2026-07-09 |
| ScioCardio ECG Analysis Platform (K252978) | Synergen Technology Labs, LLC | 2026-07-09 |
| 3D-Anywhere (K253899) | Provect.AI | 2026-07-09 |
| DIA-CEM (K261166) | DiaDent Group International | 2026-07-09 |
| LifeLens Physiological Monitor (K260157) | LifeLens Technologies, Inc. | 2026-07-09 |
| CXRDetectAI (K253751) | Neurocareai, Inc. (Dba Savelife.Ai) | 2026-07-08 |
| Alians Elbow S (K261191) | Newclip Technics | 2026-07-08 |
| BlueDop Vascular Expert (K260700) | BlueDop Medical, Ltd. | 2026-07-08 |
| cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the cobas 5800/6800/8800 systems (K260917) | Roche Molecular Systems, Inc. | 2026-07-08 |
| Denture Base Resin V2 (K262300) | Formlabs Ohio, Inc. | 2026-07-08 |
| ThermAffyx(TM) Patient Safety System (K260278) | Stihler Electronic GmbH | 2026-07-08 |
| C.A. Medical Interbody Fusion System (K254130) | C.A. Medical, LLC | 2026-07-08 |
| Electric Wheelchair (K261396) | Ningbo Resshidi Medical Devices Co., Ltd. | 2026-07-08 |
| Virtual Cone (1.0) (K260750) | Varian Medical Systems, Inc. | 2026-07-08 |
| VITEK REVEAL GN AST Assay and VITEK REVEAL AST System (K260160) | bioMerieux, Inc. | 2026-07-08 |
| Luja Soft (K262045) | Coloplast A.S. | 2026-07-07 |
| Electric wheelchair (XW-LY007 ) (K261164) | Yongkang Ruihe Metal Product Co., Ltd. | 2026-07-07 |
| HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens; HOYA Illumina (sorafilcon A) Toric Daily Disposable Soft Contact Lens; HOYA Illumina (sorafilcon A) Multifocal Daily Disposable Soft Contact Lens (K261812) | HOYA Lamphun , Ltd. | 2026-07-07 |
| Pulmonex II Xenon System (132-503) (K253942) | Mirion Technologies (Capintec), Inc. | 2026-07-07 |
| InferOperate Suite (K260973) | Beijing Infervision Healthcare Medical Technology Co., Ltd. | 2026-07-07 |
| Mobility Scooter (R200) (K261163) | Yongkang Ruihe Metal Product Co., Ltd. | 2026-07-07 |
| Cytrans™ Elashield (K253317) | GC America, Inc. | 2026-07-06 |
| TESSA Spatial Surgery System; INTELLIO Tablet (72205455) (DEN250037) | Smith & Nephew, Inc. | 2026-07-06 |